Update 007: Volume 11, Number 1 (January-February 1997)

FDA changes policy to allow experimentation on some patients without consent

The U.S. Food and Drug Administration (FDA) has amended its informed consent regulations to allow certain patients who are in life-threatening or emergency situations to be enrolled in medical research studies and experimentation programs without the knowledge or consent of the patient, the family members, or the patient’s appointed representative. The new policy, which took effect on 11/1/96, is a clear departure from the post-WWII Nuremberg Code, the ethical code developed 50 years ago as the result of medical crimes against humanity during the Nazi regime. The first principle of the Nuremberg Code states that in all medical experimentation involving humans, “The voluntary consent of the human subject is absolutely essential.”

According to the FDA, the policy change was needed “in response to growing concerns that current rules are making high quality acute care research activities difficult or impossible to carry out at a time when the need for such research is increasingly recognized.” [FDA, “Protection of Human Subject; Informed Consent,” Summary, Docket No. 95N-0158, 10/2/96]

The new policy allows for an informed consent waiver for emergency research under certain conditions, which include:

  • the “human subject” is in a “life-threatening situation” and cannot give informed consent because of his or her medical condition;
  • “available treatments are unproven or unsatisfactory”;
  • the research (which can include “randomized placebo-controlled investigations”) is necessary to “determine the safety and effectiveness of particular interventions”;
  • the research “holds out the prospect of direct benefit” to the subject, and the risks involved are “reasonable”;
  • the research “could not practicably be carried out without the waiver”; and
  • the research investigator “has committed to attempting to contact a legally authorized representative” of the incompetent patient. [FDA, 21 CFR Sec. 50.24(a)]

More than a year before the new policy took effect, the FDA issued an announcement laying the groundwork for the intended change. The release stated:

“Emergency-use products often have to be used in situations when the patient is unconscious and there is no time to locate a legal representative authorized to give consent for the use of an unapproved device or medicine. As a result, these patients are being denied the benefits of a promising new therapy, and some studies involving emergency-use products are encountering problems in enrolling patients in clinical trials.” [FDA Announcement, 9/21/95]

The FDA claims that the new policy carves out only a very “narrow exception” to its previous informed consent regulations regarding experimentation on human subjects and that the policy change actually provides stronger protections for patients who end up in emergency situations, rendered incompetent by their medical conditions. “It’s essential to protect patients, and it’s also important to give them a chance to use new therapies,” said Health and Human Services Secretary Donna Shalala. “The [FDA] proposals accomplish both. They also have broad support from industry, medical and consumer groups,” she added. [FDA Announcement, 9/21/95]

But Boston University ethicist George Annas is concerned that researchers and investigators are “just trying to make research more efficient at the expense of human rights.” “Most people would not want a doctor to flip a coin when they come into an emergency room.” According to Annas, the FDA’s claim that patients would otherwise not receive new promising therapies in emergency situations is “silly.” Experimental drugs or devices are experimental precisely because no one really knows if the treatment would be beneficial or too risky. “If we knew it would work, it would be a treatment,” he added. [New York Times, 11/5/96]

The fact that the FDA policy allows for “randomized placebo-controlled investigations” is an indication that patients’ best interests may not always be the paramount concern. The patients who receive the placebo can hardly be expected to benefit from the experimental treatment.

Critics of the new policy also point out that drug companies and medical device manufacturers have a vested interest in research and experimentation programs which would use human subjects. In the “Supplementary Information” section of the new regulations, the FDA even listed the Pharmaceutical Research and Manufacturers of America and the Health Industry Manufactures Association as two organizations which supported the policy change. But policy advocates argue that strong oversight safeguards are contained in the regulations which would protect patients from unscrupulous researchers and doctors and that the hospital’s institutional review board as well as an independent physician must agree before a patient could be enlisted without consent into an experimental program. [FDA, 21 CFR, Sec. 50.24(a)]

The British medical journal The Lancet recently ran an editorial critical of the FDA’s policy change, stating, “The needs of research have triumphed over the need for consent.” The editorial addressed, in part, the conflict of interest associated with drug and medical device research:

“We have seen enough difficulties with conflicts of interest to know that they can be subtle and are not always resolved on the side of good behaviour. Might an overly optimistic researcher, pharmaceutical company, or medical device manufacturer try to convince a community to begin, prematurely, a trial of a potentially profitable new product?” [“Voluntary consent goes down,” The Lancet, 11/16/96:1323]

The editorial then pointed to a 1994 Lancet article which reported that, in the U.S., there were already cases in which unconscious or mentally incapacitated patients were being treated with experimental drugs and devices without consent. In one New York hospital, the “do not resuscitate” orders of terminally-ill, end-stage cancer and heart patients were ignored, and instead these patients were treated with an experimental cardiac resuscitation device. In another instance, a Minnesota hospital’s institutional review board, responsible for overseeing experimental research projects, approved the testing of an experimental resuscitation device designed for adults on children as young as 8 years-old. [The Lancet, 4/30/94:1093]

Another editorial critical of the new FDA regulations appeared in The Oakland Tribune (CA) and opined, “Under the new FDA rules, consent comes not from the patient, but from a hospital board with the power to decide who will become guinea pigs, and who will die in peace.” The editorial continued:

“In fact, the FDA is essentially condoning assisted suicides by allowing doctors to experiment with drugs they know full well will kill the test subject. The FDA has declared that those tested will be patients with absolutely no chance of recovery. But who is to judge? How many times has the patient miraculously recovered after all hope had been lost?” [“New FDA rules may strip dignity from dying,” The Oakland Tribune, 1/3/97]

Adding fuel to the “slippery slope” argument — that once the informed consent requirement is waived for one group of patients, other groups will also be targeted — one professional organization has already called for the expansion of the new regulations. In a letter to the FDA, Gregory L. Henry, M.D., president of the American College of Emergency Physicians (ACEP), wrote that his organization (representing over 18,000 members) “strongly” supports the “FDA’s intent in issuing these proposed regulations.” However, Henry added the following recommendation: “The regulations should be expanded to apply not only to conditions which are life-threatening, but also to conditions that involve the strong potential for serious and permanent disability.” [ACEP letter to FDA, 11/6/95; emphasis added]

But the ACEP does not represent the views of all emergency room physicians. Commenting on the new FDA policy on the condition of anonymity, two emergency room doctors told the IAETF:

“In light of the unsavory behavior I have witnessed among my peers in response to the current ethical dilemmas inherent in capitated medical systems, I can say with complete certainty that many physicians are not up to the moral challenge of the recent loosening of FDA requirements for informed consent prior to human experimentation.”

“The new FDA rules reintroduce the dark veil of human experimentation without the right of informed consent into the practice of medicine. Patients need to know their doctor will respect their right to participate in medical care choices. Removing the requirement of informed consent strikes to the heart of the physician-patient relationship and undermines patient trust.”

Given the emphasis on patient autonomy in the U.S. and the fact that the new policy could be perceived as a possible threat to that autonomy, the FDA offered the suggestion that special medical bracelets indicating the patient’s objection to participation in experimental research should be made available. The agency also suggested that health care advance directives could be worded to reflect the signer’s desire not to be a subject used for medical experimentation. [FDA, “Protection of Human Subject; Informed Consent,” Supplementary Information, 10/2/96]

Comment: In the “Ethical Objections” section of the new policy, the FDA makes the following statement:

“The agency does not believe that this rule creates a situation that differs significantly from other emergency decisions warranting intervention in that individuals in life-threatening situations are often unable to direct decisions concerning their health care and are, therefore, unable to consent or object to a particular treatment. Yet they are routinely treated by State-licensed medical practitioners. This inability to exercise autonomy is not unique to the subjects who will be eligible for this research — it is common to the majority of individuals who may be in these life-threatening situations.” [FDA, “Supplementary Information: Ethical Objections to the Rule, 10/2/96]

Apparently the FDA has lost sight of a very basic but important distinction between medical experimentation and medical treatment. Experimentation is something that is done to a subject. Medical treatment, on the other hand, is something that is done for a patient. Ethically speaking, there is a world of difference between the action taken by emergency room doctors in providing recognized, therapeutic treatment for patients without their consent in order to try to save those patients’ lives and the action of researchers using human subjects without their consent primarily to obtain test data for a pharmaceutical company or medical device manufacturer seeking FDA approval for their product.

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IAETF Report: Supreme Court hears oral

arguments in right-to-die cases

On January 8, 1997, as hundreds of members of the disability rights organization Not Dead Yet demonstrated against assisted suicide outside, arguments took place inside the U.S. Supreme Court in two of the most important cases ever to reach the nation’s highest court. At issue in the two cases (Washington v. Glucksberg No. 96-110 and Vacco v. Quill No. 95-1858) is whether states have the right to prohibit assistance in suicide.

Defending the right of states to ban assisted suicide were New York Attorney General Dennis Vacco, Washington State Senior Assistant Attorney General William Williams and the Department of Justice’s acting Solicitor General Walter Dellinger — all of whom urged the Court to maintain the right of states to prohibit induced death, based on the distinction between letting a patient die and killing a patient.

Williams explained that states have a right to have laws against assisted suicide and euthanasia in order to protect life and prevent abuse and undue influence. Dellinger pointed out the gravity of imposing the practice of assisted suicide on fifty states, and he reminded the Court that, in the provision of health care, the “least costly treatment for any illness is lethal medication.” He further noted that the task before the Court is not to provide a cheap and easy solution to health care problems. Vacco clearly explained that the issue before the court was, “Must a state remain neutral in the face of one of its citizens asking another to help kill her?”

If the questions and comments made during oral arguments are any indication, then it was clear after two grueling hours of questions that assisted suicide attorneys Laurence Tribe and Kathryn Tucker had not been successful in persuading the Court to find that assisted suicide is a constitutionally protected right. In their arguments, Tucker and Tribe introduced phrases and descriptions that generally play well before cameras and general audiences but which were less than effective before justices concerned about the implications of striking down existing laws throughout the country.

Tribe contended that “there are 50 state laboratories out there now operating with the lights out,” where physicians end patients lives every day under a system of “winks and nods.” His claim that openly practiced assisted suicide would give patients greater control over their lives was met with skepticism by Justice Anthony Kennedy who said, “The autonomy you’re trying to project is illusory” and would “introduce fear into medical facilities” while actually diminishing patient choice.

Earlier, Tucker had argued that the right to assisted suicide was necessary for those who find themselves in a situation that is “intolerable to their personhood.” When asked if a transitory wish for death might present a problem, Tucker said any risk could be prevented by a government-imposed waiting period. However, Justice Ruth Bader Ginsberg pointed out, “You’re talking about very tight regulations,” which are rare when liberty interests are involved. “Who’s going to make all these regulations?” Ginsberg asked.

Tucker responded that once the Court finds a right to assisted suicide, the state would make the regulations. This prompted Chief Justice William Renquist to remark that there would be constant questions over regulations. His concern was echoed by Justice Sandra Day O’Connor, who exclaimed that such a situation would lead to a “glut of cases regarding this for heaven knows how long.”

But Tucker maintained that it was important for the Court to take the lead and find that a right to assisted suicide exists, since states may be unlikely to address the issue. “Ours is a culture of denial of death,” she said. Justice David Souter questioned the appropriateness of the court’s taking action that would circumvent the will of the people. He remarked that the reluctance to embrace issues surrounding death “reflects the way we are,” and that this “is legitimate when it works its way into the legislative process.”

The justices also expressed great concern about the expansion of assisted suicide. “Will it gravitate to those not terminal?” asked Souter. Ginsberg questioned how any right to assisted suicide could be available only to those who are physically able to administer the lethal medication. And Justice Antonin Scalia asked how such a right would be available to address physical, but not emotional, pain.

Tucker told the Court that the “physician is the gatekeeper” who would be charged with seeing to it that abuses did not occur. She explained that the same concerns about abuses had been raised about removal of life support and that they had proven to be unfounded. Tucker then erroneously claimed that only the terminally ill and permanently unconscious can refuse medical treatment, but backed down when Scalia asked if she was saying that the state can force a person to receive treatment for a toothache.

As for the problem of emotional pain, Tucker said that a person who had experienced emotional pain “may someday rejoice” that they were still alive. Souter reminded her that the same argument could be made regarding physical pain.

The Supreme Court is expected to hand down a decision in the two cases by the end of June.

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Protests lodged against MSU’s euthanasia drug patent

Formal objections to a permanent European patent being issued to Michigan State University (MSU) for its new euthanasia drug composition have been filed with the European Patent Office (EPO) by two German parliament members, an ethics organization, and the international pharmaceutical company which funded the compound’s development and holds the license to produce it.

As reported in the last issue of the Update (12/96:1), a temporary European patent for a euthanasia drug composition had been obtained by MSU in April 1996. But questions surrounding the wording of MSU’s patent application generated serious questions and some very alarming answers. In 1994, after a EPO examiner pointed out that MSU had not limited the composition’s use to “lower mammals,” MSU responded that there was “no intent to violate the laws of any country in reference to use in humans.” “Nevertheless,” MSU wrote, “if it should ever become legal to use the compositions in human beings, the patent claims should encompass the use of the compositions of the present invention for this purpose.”

Up until recently, MSU had been unwilling to give assurances that the drug composition would not be used on humans. In fact, in a 11/26/96 letter to the IAETF, MSU’s Office of Intellectual Properties Director Frederic Erbisch wrote that the university had not formulated any statement limiting the scope of the compound’s potential use. But, then in late December, Erbisch told Newsday that MSU had no intention of allowing the drugs to be used on humans. “We at the university aren’t looking to do anything with controlling populations of humans,” Erbisch said. [T. Maier, “Euthanasia Drug/European patent would allow human use,” Newsday, 12/22/96:A7]

That position was echoed by MSU’s president, M. Peter McPherson, in an article which ran in the university’s student newspaper. “This drug was developed for animals by a veterinarian,” McPherson said. “His intent is clearly for use on animals. We have said that again and again.” According to the article, McPherson added that, if MSU were to rewrite the patent using “narrower language,” some other company “with differing views on euthanasia” could then get a patent to use the drugs on humans. By keeping the language broad, MSU can keep control of the composition, McPherson explained. [C. Machniak, “Company fights patent on ‘U’ euthanasia drug,” The State News, 1/17/97]

But despite these assurances, formal objections to MSU’s European patent were filed in order to stop the patent from attaining permanent status on January 10, 1997. Among those were protests filed by two respected German deputies: Hubert Hueppe, a member of Germany’s federal parliament, and Roland Roesler, a Hessian State parliament member. In a joint press release, Hueppe and Roesler said they see in MSU’s patent a “grave offense against morality and considerable dangers for the public order.” “This is monstrous and deserves determined resistance, especially in Germany.” [Press release, 1/12/97]

The notion that MSU’s euthanasia compound would be dangerous for the “public order” was discussed in an article published in the Frankfurt newspaper, Frankfurter Rundschau. The article pointed out that, because the compound consists of drugs which are not controlled substances and do not need prescriptions (unlike most animal euthanasia drugs which contain barbiturates), the MSU composition could easily be obtained and used by lay people. The danger would be that, once a killing drug freely enters the marketplace, anyone can use it. The article concluded: “It should not be permitted that a drug used to commit criminal acts should be dignified as an invention.” [Frankfurter Rundschau, 1/17/97, translated from the original German]

Another formal objection filed with the EPO came from the German drug company Hoechst AG, the same company which holds the licensing agreement to produce MSU’s drug composition. Hoechst had provided MSU’s researchers with the funding necessary to develop the euthanasia compound. Heiner Harder, representing the Frankfurt-based Hoechst AG, explained that the company’s objection to the patent stems from its position that the drugs should only be used on animals. “Utilization on humans was and is completely out of the question for us,” he said. [Frankfurter Rundschau 1/17/97]

Hoechst filed its formal objection even though its U.S. subsidiary and MSU had reworded their license agreement in early January to limit the euthanasia composition uses to dogs, cats, horses, and zoo animals. Hoechst’s U.S. spokesperson, Andrea Stine, indicated that, by filing the formal protest, the company wanted to ensure that MSU could not license the drugs for humans. “We want to emphasize and make it clear that our use of this drug is for animal use only,” she said. [The State News, 1/17/97]

According to IAETF Executive Director Rita Marker, MSU’s new license agreement limiting the compound’s use to animals has no effect on the university’s European patent claims. Marker, who has been investigating MSU’s patent for months, said, “Unless the actual claims are changed, the situation remains the same — that it could be used on humans.” “What MSU is now saying is, ‘Trust us, we were trying to protect people,'” Marker added. “I find it a little hard to buy.” [The State News, 1/17/97]

Now that the formal objections to the patent have been filed with EPO, a hearing on the matter will be the next step in the opposition process.

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Florida judge rules AIDS patient can be assisted to die

Florida Circuit Judge S. Joseph Davis has ruled that AIDS patient Charles Hall has the right to end his life with the help of physician Cecil McIver. According to Davis, Hall “has a constitutional right to decide to terminate his suffering and determine the time and manner of his death,” and McIver “[a]s an individual and a physician, can determine his own ethical, religious, and moral beliefs in declining or agreeing to assist.” “Like Mr. Hall, he has the freedom of choice,” the judge ruled. [AP, 2/1/97]

Davis, a retired judge from Seminole County who was brought in to hear the case because all the Palm Beach County judges had full schedules, issued his ruling on 1/31/97, saying that the decision applies only to Hall and McIver, and only in Palm Beach County. The judge followed up with an order prohibiting county authorities from filing criminal charges against McIver if he assists in Hall’s death. That order also applies to anyone who helps McIver participate in Hall’s demise. [Reuters, 2/1/97]

The primary issue in this case was whether a 1869 state statute banning assisted suicide violates the Privacy Amendment contained in Florida’s state constitution, a provision which, McIver and Hall argued, gives a terminally-ill, mentally competent patient the right to ask for and receive a lethal prescription from a willing doctor. Davis agreed, and, in his 25-page ruling, essentially equated physician-assisted suicide with medical treatment: “The state has a clear interest in preserving life but not at the unbridled expense of individual autonomy in matters concerning a person’s medical treatment decisions.” [Tampa Tribune, 1/31/97]

Last year, another state with a similar right-to-privacy provision in its constitution also faced a legal challenge of its long-standing anti-assisted suicide statute. The state was California, and the plaintiff, John Doe, was also an AIDS patient. But in that case, Federal District Judge Consuelo Marshall ruled that “California’s right to privacy does not include a right to assisted suicide.” The judge further ruled that California’s assisted suicide law “does not create a suspect classification or implicate a fundamental right under the California Constitution.” [Kevorkian & Doe v. Arnett, Medical Board of California, & Lungren, CV-94-6089 CBM (Kx), Order, 9/11/96]

The Florida case (McIver, Castonguay, Cron, and Hall v. Krischer, Case No. CL-96-1504-AF, 15th Judicial Cir. Ct), was originally filed on behalf of three terminally-ill patients, but two of the patients with cancer (Castonguay and Cron) died before the case could be heard. All the plaintiffs and their lawyer, Robert Rivas, were hand picked by the Florida Hemlock Society and the Florida chapter of the American Civil Liberties Union (ACLU). The entire lawsuit took years of careful planning.

In the summer of 1994, the Florida Hemlock Society ran a front-page article in its newsletter recruiting terminally-ill patients and cooperative doctors to serve as plaintiffs in a lawsuit challenging the state’s assisted-suicide law. [Hemlock Beacon Newsletter, Summer 1994, pp. 1-2; see also, Update, 9-10/94:3] The legal challenge from start to finish would be a joint effort of Florida Hemlock and the Florida ACLU. According to Florida Hemlock president Mary Bennett Hudson, a retired hospice nurse, lawsuit organizers traveled statewide, interviewing almost 50 patients and more than 12 physicians in hopes of finding the ideal plaintiffs for the case. Hudson said that patients who were too depressed, too sick to withstand a trial, or too well to really be considered terminally-ill were eliminated from the potential plaintiff pool.

In the end, two plaintiffs, Hall and McIver, carried the right-to-die cause into court. “We knew we needed people who were articulate, who would make good witnesses,” Hudson explained. The semi-retired McIver, 74, a British-trained physician who went to Cambridge University and is a fellow of the Royal College of Medicine, fit the bill perfectly, as did Hall, a 35-year-old restaurant manager who contracted AIDS from a blood transfusion. McIver and Hall did not have a long-term doctor/patient relationship. In fact, they had never met before the lawsuit. “I know he’s not my regular doctor,” Hall has said, “but I trust him as much as I do my own treating physician.” [Ft. Lauderdale Sun-Sentinel, 1/12/97]

In court, Assistant Attorney General Michael Gross, arguing for the state, produced a copy of a 3/21/96 letter which McIver had written to Chuck Castonguay, one of the plaintiffs who died of cancer prior to the trial. In that letter, McIver explained in detail how Castonguay could kill himself by stockpiling morphine and other drugs, and then overdosing on the medication. Gross told the court that it was alarming that McIver, who had never even reviewed Castonguay’s medical records, went ahead and advised him on ways to kill himself, in spite of McIver’s claims that he would never consider assisting in anyone’s death without first evaluating that person’s medical condition. [Ft. Lauderdale Sun-Sentinel, 1/9/97]

For now, Florida Hemlock’s and the ACLU’s carefully strategized orchestration has paid off. However, within two hours of Davis’ ruling, the state filed an appeal. Since the appeal automatically puts a hold on the decision, Hall’s attorney asked for and got an emergency ruling from Circuit Judge Lucy Brown overturning the stay. Brown ruled that the appeal process would take time, and Hall would be “forced to suffer a miserable and degrading death.” But the very same day that Brown issued her ruling, Associated Press quoted Hall as saying, “I’m far from ready to die,” and that he hopes death comes peacefully and naturally. [AP, 2/6/97; Miami Herald, 2/6/97]

The state has appealed Brown’s ruling as well, reinstating the stay. Meanwhile, the 4th District Court of Appeals refused to review Davis’ ruling and, instead, forwarded the case directly to the Florida Supreme Court. [Ft. Lauderdale Sun-Sentinel, 2/7/97]

Related: In his ruling, Judge Davis urged the state legislature to address the assisted suicide issue. But, according to Jim Towey, director of the FL Commission on Aging with Dignity, “I don’t think anyone wants to touch the issue with a 10-foot pole.” That assessment was confirmed by the Florida Hemlock Society. The group has contacted all 160 state legislators and found no one willing to file a bill legalizing assisted death. [Tampa Tribune, 2/4/97; Miami Herald, 2/4/97] In addition, the Florida Board of Medicine has voted to oppose physician-assisted suicide. Commenting on the 2/8/97 vote, Board Chairman Edward Dauer said, “The board is not going to allow physician-assisted suicide.” “We’re not going to give an open-ended invitation to Dr. Kevorkian to come into Florida,” he explained. “The doors are closed.” [Tampa Tribune, 2/9/97]

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Kevorkian: Legal battle and deaths continue

     

  • Judge finds no constitutionally protected right to die and rules Kevorkian can be prosecuted

On 1/3/97, U.S. District Judge Gerald Rosen ruled that there is no right to assisted suicide guaranteed by the U.S. Constitution and that Michigan authorities can, indeed, prosecute Jack Kevorkian. The ruling came as a result of a lawsuit filed by Kevorkian and his associate Janet Good, the former head of the Michigan Hemlock Society, asking for an injunction prohibiting Oakland County (MI) Prosecutor Richard Thompson and his successor from prosecuting Kevorkian or Good in the future. The suit also asked that the Michigan Supreme Court ruling that assisted suicide is a common law felony be found in violation of the U.S. Constitution.

In his strongly worded decision, Rosen rejected the findings of both the Ninth and Second Circuit Courts of Appeals that laws banning assisted suicide violate the 14th Amendment’s Due Process and Equal Protections Clauses, respectively. Since the U.S. Constitution does not guarantee a right to assistance in death, Rosen held that the Michigan Supreme Court’s ruling that assisted suicide is a common law felony is not unconstitutional. According to Rosen:

“In a democracy, judges are not free to simply look at the Constitution and declare new rights to correct every perceived wrong, for if the Constitution comes to mean everything to everybody — a veritable grabbag of rights — it will mean nothing when we really need it to protect those fundamental rights which are clearly delineated, because its legitimacy and grandeur will have been drained from it.”

In an attached footnote, the judge commented further:

“[T]he court cannot help but observe that we live in an age of instant gratification — people want things when they want them and how they want them…. Indeed, it sometimes seems that the Judiciary is in danger of becoming the ‘fast-food’ institution of government. (If we are not careful, the sign ‘Welcome to McJustice’ may replace ‘Equal Justice Under the Law’ above courthouse doors.)” [Kevorkian v. Thompson, No. 96-CV-73777-DT, slip op. (amended) (D. Mi E.D. Jan. 6, 1997) at 41]

Rosen denied the request for an injunction barring future prosecutions of Kevorkian and Good in Oakland County. [p. 58]

     

  • Oakland County drops charges as Ionia County pursues Kevorkian prosecution
  •  

When Oakland County Prosecutor Richard Thompson left office on 12/31/96, Jack Kevorkian faced 19 criminal counts from 10 assisted deaths in Oakland County since the previous June. Also facing charges were two of Kevorkian’s cohorts, medical supply dealer Neal Nicol and psychiatrist Georges Reding. (See Update, 10-11/96:6] But when the newly elected prosecutor, Dave Gorcyca, took office, all of that changed.

Making good on campaign promises not to waste taxpayer’s money by prosecuting Kevorkian under Michigan common law, Gorcyca dropped all charges against Kevorkian, Nicol, and Reding. “It is my judgment that the common-law prohibition against assisted-suicide is all but unenforceable,” Gorcyca told reporters. “Hypothetically, we can charge and convict Doctor Kevorkian 100 times,” Gorcyca said, “but since we aren’t making law nor are we setting precedents, what are we really accomplishing other than wasting a lot of taxpayer money.” Gorcyca claimed that the charges, filed when his predecessor was still in office, had been “written in haste” and “without full investigation” and that the Michigan legislature should “pass a clearly enforceable law controlling assisted suicide.” Until that time, he said, “there is little the prosecutors of Michigan can do effectively.” But former prosecutor Thompson disagreed, saying that dropping all the charges amounted to “de facto legalization of assisted suicide” in Oakland County and that Gorcyca’s rationale was “just a gigantic excuse for not doing his job to enforce the law.” [Oakland Co. Prosecutor’s Office, Press Release, 1/10/97; Detroit Free Press, 1/11/97; Detroit News, 1/11/97; New York Times, 1/11/97]

Ionia County Prosecutor Raymond Voet, however, is not backing off a grand jury indictment of Kevorkian on four felony counts in the assisted death of Ionia resident Loretta Peabody. (See Update, 10-11/96:6.) In a highly unusual move, Voet — concerned that evidence crucial to his case would be returned to Kevorkian after Oakland County dropped all charges — obtained a search warrant and seized the evidence from the Bloomfield Township Police Department in Oakland County. The evidence in question had been obtained by Bloomfield police after they interrupted a meeting between Kevorkian and his 40th victim, Isabel Correa, in her motel room the night before she died. The evidence included a video tape of Peabody, her husband, Kevorkian, and Janet Good filmed in the Peabody’s Ionia home prior to her death. Also among the items were Kevorkian’s “suicide machine” and a portable armrest containing two drops of blood. Voet called the seizure of the evidence “a rescue mission.”

Kevorkian attorney Michael Schwartz, arguing that Voet “literally stole this property,” filed in Oakland County to have the evidence returned. But District Judge Edward Avadenka ruled that, since the items in question were already in Ionia County and Voet had a valid search warrant to obtain the evidence, any challenge would have to be conducted in Ionia County. A hearing to do just that is scheduled for 2/18/97 before Ionia County Circuit Judge Charles Miel. [Detroit Free Press, 1/21/97, 1/31/97]

     

  • Two more deaths in Oakland County
  •  

While there has been no formal admission, everything points to the fact that Kevorkian has added two more women to his ever-increasing body count. Within hours of each other on 2/3/97, the bodies of Elaine Day, 79, from Newhall, CA, and Lisa Lansing, 42, of Florham Park, NJ, were brought to the attention of Oakland County authorities. Day’s body, with no identification, was abandoned in Kevorkian’s old rusted van, which was parked in back of the Oakland County morgue. Lansing’s body was delivered by a friend, Margaret Johnson, to Pontiac Osteopathic Hospital, one of Kevorkian’s usual dumping sites. Neither woman was terminally ill, and Lansing, like three other Kevorkian victims before her (Marjorie Wantz, Rebecca Badger, and Judith Curren), had no signs of physical illness upon autopsy. Both women died from overdoses of potassium chloride.

Police have said that Lansing’s body was wrapped in a mink coat when Johnson delivered the body to the hospital. Johnson then took the coat and wore it on her return trip to New Jersey. She is the sole beneficiary of Lansing’s $500,000 estate, raising serious conflict of interest questions. Lansing’s mother and sister did not know about Lansing’s plans to go to Michigan. When the Detroit Free Press contacted Johnson at her home, she said that her relationship with Lansing was “none of anybody’s business” and referred all inquiries to her lawyer, Geoffrey Fieger. [Detroit Free Press, 2/12/97; UPI, 2/5/97; Detroit News, 2/4/97]

While not outright confirming Kevorkian’s involvement in the two deaths, Fieger, who is Kevorkian’s lead attorney, told reporters, “You have to have been born under a rock yesterday not to know who was involved in these cases.” “Nobody else does these.” [Detroit News, 2/6/97] Ionia County Prosecutor Raymond Voet said Fieger’s acknowledgment was enough for him to ask a judge to revoke Kevorkian’s bond and possibly put the death doc in jail. Kevorkian had been released on personal bond in the Ionia County case as long as he did not assist in any further suicides. [Detroit News, 2/7/97]

Oakland County prosecutors have decided not to charge Kevorkian in Lansing’s death, saying that any Kevorkian link is “all speculation.” Day’s death, ruled a homicide, is still under investigation. [Detroit Free Press, 2/12/97; AP, 2/12/97]

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Australia grappling with euthanasia law

     

  • Senate committee hears testimony on euthanasia law

Australia’s national Parliament appears likely to repeal the Northern Territory’s (NT) euthanasia law, if the tone of a recent Senate committee inquiry is any indication. Parliament’s House of Representatives has already passed Kevin Andrew’s “Euthanasia Laws Bill,” which would prohibit Australia’s three territories from passing laws permitting euthanasia or assisted suicide (see Update, 12/96:3). The Senate, Parliament’s upper house, postponed its vote and sent Andrew’s bill to a committee to study its constitutional implications. The national Parliament has constitutional power over the country’s territories, but not its states.

As part of its investigation, the Senate Legal and Constitutional Legislation Committee held a public hearing in Darwin, the NT capital, and heard testimony from 51 people, including euthanasia supporters Marshall Perron (the author of the NT euthanasia law), NT Chief Minister Shane Stone (who says he is personally opposed to euthanasia, but, as head of the NT government, must support the NT law), and Dr. Philip Nitschke (dubbed Australia’s “Dr. Death” for his involvement in three deaths under the NT law).

During the hearing, generally hostile comments from the six committee senators prompted the media and others to speculate that the Senate will probably follow the House and pass Andrew’s euthanasia repeal bill. Chief Minister Stone told reporters that he was enormously disappointed with the committee hearing because it appears that the senators have already made up their minds in opposition to NT’s euthanasia law.

The committee is scheduled to hold two more hearings in Canberra in February before it submits its final report to the Senate. A full Senate vote on Andrew’s repeal bill is expected sometime in March. [Australian Broadcast Co. News, 1/24/97; Australian AP, 1/24/97; NY Times, 2/2/97]

     

  • Two more deaths under NT euthanasia law

Dr. Philip Nitschke and his life-ending laptop computer and “Deliverance” software program have been involved in two more deaths. Janet Mills, 52, traveled to Darwin from her home in South Australia to become the second casualty under the Northern Territory’s euthanasia law. Mills, who had cancer, died on 1/2/97 using Nitschke’s computer-driven device to administer a dose of lethal drugs intravenously. Mills had been the subject of much media attention as she tried for more than four weeks to obtain a cancer specialist’s signature on her death request which was thought, at the time, to be a requirement under the NT law. The struggle to obtain the needed NT specialist signature prompted calls for amending the euthanasia law so that it would be less restrictive. But, shortly after Mills’ death, NT Attorney General Denis Burke clarified the issue by stating that the law does not require that a NT specialist in the patient’s disease actually sign the request, only that a specialist has to be consulted. The request can be signed by any medical practitioner after consultation with a specialist. [Australian AP, 1/7/97; Sydney Morning Herald, 1/7/97]

Little is known about the third patient to die under the NT law other than he had cancer, was 69 years-old, was from the NT, and used Nitschke’s computer program. Details of the man’s 1/20/97 death were not released by Nitschke, and National Coalition for Voluntary Euthanasia spokesman Dr. Robert Marr said, ‘From now on, I don’t think there’ll be any need to announce future deaths. It should be a private matter.” [Sydney Morning Herald, 1/23/97; The Australian, 1/23/97]

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Editorial: Risking young lives

It could be just a coincidence, but, then again, maybe not.

Recent reports of increased incidences of teen suicides and attempted suicides in Australia and Michigan are becoming alarming.

On 1/28/97, the Australian Broadcast Company reported that, because of a 200 percent increase in youth suicide since 1993, various Queensland youth groups have demanded that a national task force be created to probe the issue, determine causes, and find solutions. Prior to that, Victoria’s premier, Jeff Kennett, announced the formation of a regional task force to tackle Victoria’s “unacceptably high” teen suicide rate. [The Age, 12/31/96]

Meanwhile, in Oakland County, Michigan, Oxford High School has been reeling from one successful and four attempted student suicides, accounting for five of over 15 suicide tries in the district since the school year began. The method most often used: overdoses of prescription and over-the-counter drugs. [Detroit Free Press, 12/31/96; Detroit News, 1/28/97]

Is it coincidental that these sharp increases in teen suicidal behavior just happened to occur in areas where the debate over assisted suicide and euthanasia has been most intense? Perhaps. But the “right to die” movement does carry with it an inherent message that could possibly lead some emotionally wounded teens to view death as a preferable option to life. It’s a message that can be subtle, often overlooked by society at large.

Oakland County is Jack Kevorkian’s deadly playground, his private killing zone. Three juries now have acquitted him of any wrongdoing in the assisted deaths of five people. So Kevorkian (with the aid of spin lawyer Geoffrey Fieger) continues to claim that he just helps suffering people free themselves of physical and emotional pain through death. And the legal system, at least in Oakland County, no longer protects these vulnerable, suicidal lives.

So what is the message that Oakland County teens hear? It’s the same message that Australia’s youth have heard every time there’s a euthanasia death under the Northern Territory (NT) law: The answer to seemingly insurmountable personal problems and suffering is to end your life.

Kids aren’t stupid. They hear and process information sometimes better than we adults. And often the clear messages teens hear are not at all that clear to busy, otherwise occupied adults.

For example, while Kennett, Victoria’s premier, has voiced deep concern over the high rate of adolescent suicide, he has also publicly and passionately supported the practice of euthanasia. Commenting on the much publicized death of Janet Mills, the second patient to die under the NT euthanasia law, Kennett told reporters that Mills had “exercised her right as a citizen after a great deal of thought,” that her death was “beautiful,” and that her right to die was undeniable, given her pain. [The Age, 1/7/97] If that was the case, how could the death of an emotionally pain-filled teenager be any less noteworthy, any less “beautiful,” or, for that matter, any less a “right”?

The Australian Institute for Suicide Research and Prevention’s (AISRP) web site is an example of just how much the “right-to-die” movement has influenced the field of suicide prevention. On its web page designed to provide help for teens contemplating suicide, the AISRP has a section entitled “The Right to Die.” It poses the question, “Doesn’t a person have the right to die?” The answer in its entirety is:

“Death causes a huge amount of distress to families and friends. Also death is a permanent no return state. It doesn’t allow for any other options to be tried. Therefore it would be reasonable to check out all the other options before making a final decision.” [www.gu.edu.au/gwis/aisrap/young.htm]

Picture a depressed and possibly despairing teen reading that response. The message: You have the right to die; it’s an option among many to be considered. Just be “reasonable” and sure, because you can’t come back. How affirming!

According to the American Academy of Child and Adolescent Psychiatry’s “Teen Suicide” factsheet, thousands of teenagers commit suicide each year in the U.S. In fact, suicide is the third leading cause of death among 15 to 24 year-olds, the sixth leading cause of death among 5 to 14 year-olds. That’s serious stuff.

The superintendent for Oxford High School’s district, Marion Ginopolis, has struggled to find some pattern, some reason for the rash of teen suicide attempts this school year. “We couldn’t find any patterns,” Ginopolis said, “It’s frustrating.” “The problem is not what they know, the problem is how they behave. That’s a community and home issue, not a school issue.” [Detroit News, 1/28/97]

Is there a connection between assisted suicide/euthanasia and teen suicide?

Why would we even want to risk it?

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Depression seriously undertreated in U.S

According to a recent article in the Journal of the American Medical Association (JAMA), “There is overwhelming evidence that individuals with depression are being seriously undertreated.” That is the conclusion of a consensus panel, organized by the National Depressive and Manic-Depressive Association (NDMDA), which studied the issue for almost a year. Reasons for undertreatment can be attributed to health care providers, patients, and health system factors, even though there have been effective treatments for depression available for over 35 years.

Doctors often fall short of adequately diagnosing and treating depression for a number of reasons, including the failure of medical schools to provide sufficient training for psychiatric diagnosis and interpersonal skills, the misguided belief that psychiatric disorders are not “real” illnesses, insufficient time given to diagnose and treat depression, poor insurance coverage influencing doctors’ decisions on whether to treat patients with depression, a lack of communication between health care providers, and doctors prescribing insufficient dosages of antidepressant medication for too short a time.

Patients also can contribute to the problem of undertreatment by failing to recognize depression’s signs and symptoms, underestimating the severity of depression, being reluctant to see a mental health specialist, and not following treatment regimens. Additionally, the panel concluded, “Finally, many managed health care systems create barriers to prescribing the best antidepressant medication, discourage the proper monitoring of patients, and do not allow for the proper recognition of the chronic and recurrent nature of depression. Too many patients with depression are treated for very brief periods of time and then lost to the health care system.” [R. Hirschfeld et al., “The National Depressive and Manic-Depressive Association Consensus Statement on the Undertreatment of Depression,” JAMA, 1/22-27/97:333-340]

According to a JAMA press release on the NDMDA article, “Depression is one of the most frequent of all medical illnesses.” In patients who have been previously hospitalized for depression, there is a 15 percent chance of death from suicide. [JAMA press release, 1/22/97]

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News of note

  • Once again Dr. Gerald Klooster, Sr., has been returned to his wife, Ruth, in spite of previous brushes with death while under her care. The elder Klooster, who has Alzhiemer’s dementia, was the subject of a bitter custody fight between family members in both California and Michigan. When his son, Dr. Gerald “Chip” Klooster, discovered that Ruth, a Hemlock Society member, had arranged to bring his father to Jack Kevorkian, Chip foiled his mother’s plans by taking Gerald, Sr., to live with him in Michigan. But, after an ugly court battle, the elder Gerald was placed in the custody of Chip’s sister, Kristen Hamstra, in California, and later returned to Ruth. Then on 9/24/96 — after Ruth tried to stop paramedics from helping her husband when he was found unconscious on the kitchen floor from an apparent overdose of sleeping pills — California Superior Court Judge William McKinstry revoked Ruth’s custodial rights, saying that she had not handled the situation appropriately. The police ruled the incident “an attempted suicide with suspicious circumstances.” (See Update, 10-11/96:10.) But then on 2/7/97, McKinstry placed the elder Gerald back into Ruth’s care after she assured the judge that she had made their house safe by installing an alarm system, putting safety latches on doors and cupboards, and ridding the house of all alcohol and medications other than her own. McKinstry also agreed to allow Ruth to take her husband out of state as long as she notifies her daughter Kristen first. [Contra Costa Times, 2/8/97; San Francisco Chronicle, 2/8/97]
  • In a 9-0 decision, the Supreme Court of Canada has ruled that Robert Latimer, the Saskatchewan farmer who admitted gassing his 12-year-old disabled daughter to death in 1993, will get a new trial. The decision, written by Chief Justice Antionio Lamer, found that Latimer deserved a new trial because the government prosecutor had instructed police to question prospective jurors concerning their views on religion and euthanasia. Five of those jurors ended up on the jury that convicted Latimer of second-degree murder in 1994. The Supreme Court, however, denied Latimer’s petition to quash his confession, which his lawyers argued was obtained without the police properly advising him of his rights.Latimer had been sentenced to life in prison without possibility of parole for ten years. He has spent only one day in jail, having been released on $10,000 bond pending his appeal. Latimer had confessed to police that he planned Tracy’s death for days, getting just the right size pipe and tubes to connect his truck’s exhaust system to the cab where he placed Tracy, a child with severe cerebral palsy. He settled on that plan after rejecting previous thoughts of shooting her in the head and setting her body on fire. The case caused a furor throughout Canada. Many citizens saw Latimer’s conviction as an outrage because, they said, Latimer was being a loving father who just wanted to end his daughter’s suffering. [See Update, 11-12/94:7] But disability rights advocates saw Latimer as a murderer and the case as a clear message of society’s willingness to devalue the lives of people with disabilities. [The Vancouver Sun, 2/6/97; AP, 2/6/97; UPI, 2/6/97; Leader Post, 2/6/97]
  • In The Netherlands plans are underway to make the practice of reporting euthanasia cases more attractive to doctors. Under recently revealed measures, euthanasia cases will no longer be referred to public prosecutors. Instead, those cases will be submitted to an independent committee made up of legal, medical, and ethical experts. The change in policy is expected to be less threatening to doctors who would otherwise not report induced death cases for fear of prosecution. “The nature of criminal law is very black and white,” said Justice Minister Winnie Sorgdrager. “We need a more nuanced assessment (of euthanasia cases),” she said. Euthanasia and assisted suicide still remain technically illegal in the Netherlands. [Reuters, 1/21/97]
  • Noel Earley, 48, the man with Lou Gehrig’s disease who, along with the ACLU, planned to challenge Rhode Island’s assisted-suicide ban, died naturally in his home on 1/15/97. “He died very comfortably,” said his nurse, Kathy Bedard. Earley and his cause had been featured on ABC’s Nightline in early January. [UPI, 1/15/97; AP, 1/15/97]
  • On 2/4/97, Virginia’s State Senate overwhelmingly passed a bill banning physician-assisted suicide. SB 788, which passed by a vote of 27-12, would impose a fine up to $100,000 on any health-care provider who assists in a suicide, and also allows grieving family members to sue that provider for “any losses suffered.” The bill even contains a provision whereby family members or medical professionals can obtain a court injunction to stop any assisted suicide they believe is about to occur. Doctors and other health professionals could also face the permanent loss of their licenses if they assist a suicide. Sen. Mark Earley, sponsor of the bill, said the measure is needed because Virginia’s current law is “murky”; it does not ban assisted suicide outright, but rather states that euthanasia is not condoned. [Richmond Times-Dispatch, 2/5/97; Virginia Pilot On-line, 2/5/97; Reuters, 2/6/97]